Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dry Eye Syndromes
- Sponsor
- Allergan
- Enrollment
- 185
- Locations
- 3
- Primary Endpoint
- Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.
Detailed Description
Participants will be randomized to a single application sequence, either sequence "A" (intranasal application followed by control application) or sequence "B" (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Moderate to severe dry eye disease
- •Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
- •Literate, able to speak English, and able to complete questionnaires independently
Exclusion Criteria
- •Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
- •Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
- •Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
- •Corneal transplant in either or both eyes
- •A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
Outcomes
Primary Outcomes
Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
Time Frame: Pre-application to Post-application on Day 0
The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to "no dryness" and 100 corresponds to "maximal dryness". A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
Secondary Outcomes
- Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score(Pre-application to Post-application on Day 0)